1. Field of the Invention
This invention relates to a method, apparatus and system for anonymously providing medical data for humans including infectious status.
More particularly, the present invention relates to anonymously providing medical data for humans via unforgeable correlation characteristics.
In a further and more specific aspect, the instant invention concerns a method and apparatus for voluntarily and anonymously providing medical data for humans and allowing the subject to share that information with a chosen associate or associates.
2. Prior Art
Medical data collection, storage and display systems of great variety in construction and purpose are often employed for medical and non-medical purposes. Examples include the systems described in U.S. Pat. No. 4,737,912 entitled "Medical Image Filing Apparatus", issued to Ichikawa, hereby incorporated herein by reference, directed to a medical image filing and display system and the like.
Another example is described in U.S. Pat. No. 5,193,541 entitled "Health Examination Method And System Using Plural Self-Test Stations And A Magnetic Card", issued to Hatsuwi, hereby incorporated herein by reference. This patent is directed to a system for storing medical data on magnetic media contained on a card, wherein the patient provides samples and the like to a variety of testing stations that also record the self-test data on the card.
A further example is taught in U.S. Pat. No. 5,325,294 entitled "Medical Privacy System", issued to Keene, hereby incorporated herein by reference. This patent describes a system and method for retrieving medical data from a database and sharing these medical data voluntarily with another party while protecting against unauthorized access by unauthorized parties.
A feature common to such systems is a means for identifying a particular patient or client and the associated, relevant medical records. Two particular and possibly overlapping areas where such concerns arise are: (I) sample collection and (II) testing to determine human health characteristics including infectious status of humans, and especially HIV status.
.sctn. I. Sample collection.
Various types of samples may be collected for various purposes, including blood typing, drug testing and testing for infectious or genetic diseases. Depending on the purpose of the testing, various specific biological specimens may be collected. Often, but not always, these are bodily fluids. In some cases, tissues, hair or nail clippings may be preferred.
A. Urine testing.
Several commercially available urine test specimen collection devices and systems are known for collecting and identifying human urine donated as test material. Typically, these collection systems have a plastic receptacle or reservoir into which the test subject urinates and a plastic top or cover which attaches by threaded attachment.
As with most specimens for laboratory testing, it is desirable to have a way of linking the specimen as originating from the test subject from which the specimen is collected. This linked identification is needed in order to allow the testing laboratory to report results correctly linked to the individual from whom the test material was obtained. Typically, the name of the test subject and other identifying indicia are written by hand on a label (or, alternatively, a computer-generated label is prepared including the linking data) and the label is affixed by adhesive sticker to the urine container or urine collection device side wall.
This label, attached either after or preferably prior to urine donation, is affixed to the receptacle side wall rather than the top because the currently available urine containers have tops which are often interchangeable from container to container. Thus, a label attached only to the top can be inadvertently transferred with another top and transferred to another container, incorrectly placing thereby the name of one patient onto the urine container holding the urine of a different patient. This may result in erroneously reported lab results leading to improper diagnosis and treatment of the patient or improper identification of one individual as having used some drug or substance.
Further, in testing of human urine in the laboratory, there is a need from time to time for anonymity in certain circumstances such as in double blind studies or where the test subject wishes to have anonymity as in HIV testing and in certain circumstances for urine drug testing associated with employment. In such circumstances, one known method for accomplishing the task of secure and specific identification of the specimen to the test subject while maintaining anonymity has been to attach a unique alphanumeric identifying number or code via a label that is attached to the sample collection container or device.
A first limitation of such a numerical system is that one subject may give the corresponding chit to a second individual and then the second individual may portray the test material and test results as originating from and linked to him- or her-self rather than from the true test subject. A further limitation is that the alphanumeric code, if provided to the test subject or researcher in the form of a disposable paper chit, may be lost. Correlation of the test specimen and container or device may then be hindered or completely corrupted. Additionally, computerized linkage of an alphanumeric code to other data may be subject to input error by a keyboard operator in some circumstances.
Where these types of records are drug testing results, they are usually collected by and for a single employer; a subsequent employer may well be denied access to these records for any of many reasons. A prior employer may wish to limit liability against suit by a dismissed employee, and the employee may well dispute the accuracy of the testing process. Because samples are typically labeled before or, alternatively, after testing, possibility of confusion between test subjects is a very real concern.
What is needed is a system, apparatus or method wherein a secure and verifiable yet anonymous identification and linkage is established between the urine sample collection device or container and the urine donation. Ideally, this linkage occurs or is established simultaneously with collection of the urine sample. Furthermore, there is a need for urine specimen collection devices that are anatomically easy to hold and use and that, at the same time, allow for ease of affixing of identifying data to the collection device.
B. Phlebotomy blood sample collection.
Samples of blood are typically collected by puncturing the skin and removing by vacuum a sample of whole blood. A tourniquet is typically applied to the arm or in some cases the leg of the test subject and the skin surface is swabbed with alcohol to disinfect. Subsequently the test subject is asked often to grip a rubber grip so that the natural muscle compression leading to blood flow in the venous system is utilized to cause the vein to engorge and swell indicating that blood volume has increased in the vein. Then a needle attached to a syringe is inserted into the vein and a quantity of blood is removed. Other common means of phlebotomy or blood sample procurement are via indwelling lines such as catheters or by blood lancet puncture of skin such as infant heel and subsequent daubing of blood from skin surface into capillary tubes or absorbent paper card.
C. Oral mucosal transudate sample collection.
Oral mucosal transudate (OMT) samples may be collected and these may be tested to determine either infectious disease status or to identify foreign substances, such as therapeutic or recreational drugs, present in the body. Breathalyzer tests are frequently administered, especially in the context of testing drivers for alcohol intoxication. In both instances, chain of custody issues may render the sample inoperative or inappropriate in medical evaluation and/or as legally operative evidence.
D. Breathalyzer sampling.
Commercially available breath test collection devices are employed, for example, to assess human alcohol level by measurement of breath alcohol levels. Typically these devices utilize roadside measurement and the test is administered by law enforcement officials. Use of the resulting alcohol measurement number is envisaged for subsequent legal proceedings. In order to do so, a positive means for identifying the test subject is needed. All of the currently available breathalyzer systems incorporate means of identification of the specimen as originating from the test subject from whom the specimen is collected such as photo or driver's license number or the like. In order to maintain specimen integrity and to link the results to the individual from whom the breath test material was taken, the name or other numerical identifier of the test subject is typically written or affixed by coded sticker or the like attached to the printout of the test results. The limitation of such a numerical identification system is that one attorney may allege that the corresponding test subject is not the attorney's client but rather some other individual and then the test results may not be admissible in court. Alternatively, the test subject is taken to a hospital where a blood sample is taken and a legal chain of custody is maintained for results to be acceptable to a court of law. This procedure involves time and expense for the law enforcement official and laboratory.
E. Hair and fingernail sample collection.
Hair and fingernails both include metabolites of substances ingested by the subject and either may be used to determine drug use in particular. Both types of samples are subject to contamination from external sources, e.g., walking through a room laden with marijuana smoke or working with the hands immersed in chemical baths. For these and other reasons, testing of this type of specimen has not met with widespread acceptance. Additionally, chain of custody is an issue relevant to testing these types of specimens.
.sctn. II. Sample evaluation.
Once collected, biological samples are evaluated to determine a variety of characteristics. These include (A) drug testing, (B) testing for diseases such as infectious diseases and (C) testing to identify genetic predisposition for developing disease.
A. Drug testing.
Drug testing may be carried out on any of many types of samples collected from a test subject. Urine testing is particularly common and is widely believed to be less intrusive than testing that measures for metabolites over a longer interval of the test subject's recent life. Hair samples, for example, may be tested to determine drug usage over a relatively long period of time, however, relatively little is known about the actual accuracy of such tests. Breath samples and oral mucosal transudate samples may provide useful or legally significant information regarding recent drug use or about disease status of the individual.
B. Infectious disease monitoring.
Human disease status is highly confidential information subject to misuse by any of a variety of agencies or individuals. For example, some doctors will advise patients not to seek human immunodeficiency virus (HIV) testing via the doctor because the records generated in the process of testing for HIV may be used by insurance companies to deny insurance coverage to the individual requesting the test results.
The reasoning seems to be that if the individual sought to ascertain HIV status information, the individual must have reason to suspect a positive HIV status. The individual therefore is adjudged likely (i) to have engaged in high-risk behavior, (ii) to continue to engage in high-risk behavior and (iii) to have an enhanced probability (compared to other population segments) of developing (a) HIV-positive status and (b) later, acquired immune deficiency syndrome (AIDS), presently a frequently fatal condition. People may well be denied employment if it is suspected that they are at risk of developing an HIV-positive status or of contracting AIDS subsequent to infection by HIV.
Accordingly, it is desirable, particularly with respect to HIV testing, to be tested in a way that completely protects the individual identity of the test subject. One such system is provided in some states through Planned Parenthood, which (i) collects a blood sample from the test subject and (ii) collects whatever identifying indicia the test subject cares to provide, such as a pseudonym. The agency typically then (iii) links the identifying indicia, the test sample and a unique identifying code or serial number in a computer database or other log and (iv) informs the test subject that test results are to be expected to be available following a set interval of one to two weeks, which interval is for shipping the test sample to a suitable laboratory or other testing facility and receiving the results of the analysis therefrom.
The test sample and code or serial number are then (v) sent to a remote site for testing and analysis. Results are then (vi) sent back to the test site (or any other designated place). The test subject (vii) returns to the test site or goes to a designated office and (viii) is advised of the test results. If warranted, (ix) appropriate counseling is provided along with follow-up services. Additionally, (x) a paper record is often provided with an indication of the test results.
Unfortunately, because the test subject often provides a pseudonym, a third party has no way of knowing that a particular record is actually the product of a test conducted on samples provided by the individual presenting such a record. Moreover, the paper record is easily forged or mutilated to alter the information contained thereon, in part because there is no standard or unforgeable format for such records. In short, this system affords an individual test subject great confidence in both the anonymity and the trustworthiness of the test result, but this system does not provide the test subject with any verifiable way of providing the test results to a third party. Additionally, recent multiple-drug therapies can reduce presence of HIV and indicia of HIV to immeasurably low levels but these therapies introduce detectable levels of drugs into the bloodstream of the test subject.
Further, the situations in which people might meet and desire to know or communicate to each other the infectious disease status of one another do not lend themselves to accessing of data during the course of normal business hours. Social settings in which persons might meet and form a mutual desire for sexual activity tend to be focused on hours other than normal business hours, for example, in the evening at a nightclub. If there were a method for reliably and anonymously exchanging information such as indicia of HIV-negative status and the date on which the sample providing this result was collected, it would need to be useful in such settings or in conjunction therewith in order to be effective in controlling the spread of this deadly disease.
Accordingly, it is desirable to provide reliable data on health and/or infectious status in an anonymous fashion whereby the person viewing the data has some assurance that the data correspond to the individual with whom they are considering carrying out such activities. However, this alone is not necessarily sufficient because it is desirable to be able to have access to the data on a twenty-four-hour-a-day basis, and also because identification cards and the like may not correspond to the bearer thereof. Therefore, it is appropriate and useful to base the correlation process on parameters unique to the individual whilst continuing to ensure anonymity of the test subject, the test results and the fact that the test subject had the testing performed.
C. Genetic testing.
Laboratory testing for genetic markers of disease and hereditary susceptibility to diseases or specific conditions is a rapidly developing area of medicine. Current methods include DNA and RNA analysis based on hybridization techniques such as fluorescence in situ hybridization, restriction length polymorphism and polymerase chain reaction for amplification of nucleic acid.
The diseases and hereditary predispositions to disease for which genetic testing is currently available include sickle cell anemia, muscular dystrophy of various types, fragile X disease, chronic myelogenous leukemia, predisposition to development of cancer such as breast cancer gene BRCA-1 or colon cancer gene. These issues have had considerable public attention focused on them because they may be used to discriminate against some people in specific settings, e.g., in the making of hiring and downsizing decisions, in permitting the individual to obtain health insurance and the like.
A woman with BRCA1 has a lifetime risk of developing breast cancer of 85% versus 11% lifetime risk for a woman who does not have the BRCA1 gene. Surveillance by mammogram or other means to detect the earliest sign of tumor in the high risk women is prudent. Newer techniques, such as DNA chip technology, portend cost reductions and more widely available testing in the near future.
In order to combat these varied problems, some form of correlation that is unique to the individual, that is not based on a photograph or the like of the individual and that does not employ a transferable or forgeable identity device (such as an identity card) is required. The form of correlation needs to be highly reliable and also must operate rapidly in real time to provide "go/no-go" identification in a short period of time (e.g., a minute or less).
While the various mentioned prior art devices function as apparatus for collecting, storing and retrieving human medical data, certain inherent deficiencies preclude adequate, satisfactory performance of the purpose of reducing risk of exposure of the individual identities of persons using the system.
It would be highly advantageous, therefore, to remedy the foregoing and other deficiencies inherent in the prior art.
Accordingly, it is an object of the present invention to provide improvements in anonymous human health and/or medical data collection and retrieval.
Another object of the present invention is the provision of an improved method and apparatus for anonymously providing human health and/or medical data in a secure and tamper-free fashion that allows a person to share those data with another party.
An additional object of the instant invention is the provision of an improved method and apparatus for providing human health and/or medical data in a way that allows another party to have great confidence that the data provided are reliable and that they correspond to the party rendering the data available to them.
Still a further additional object of the present invention is to provide an improved method, apparatus and system for anonymously collecting human health and/or medical data and allowing retrieval of the data in a secure fashion that permits twenty-four hour access thereto.
And another object of the present invention is to provide an improved method, apparatus and system for collecting, storing and retrieving human health and/or medical data in an anonymous fashion that does not rely on forgeable identification devices.
Still another object of the present invention is the provision of a method, system and apparatus for displaying and sharing human health and/or medical data with a chosen person or people.
Yet another object of the instant invention is to provide a method, system and apparatus for retrieving human health and/or medical data in a secure fashion that also provides a high degree of confidence in the test subject of the anonymity of the test subject.
Yet still another object of the instant invention is the provision of a method, system and apparatus for identifying individuals free of HIV indicia in a reliable and anonymous fashion in order to stem the spread of a presently a frequently fatal disease.
And a further object of the invention is to provide a voluntary method, system and apparatus for identifying individuals who are free of HIV indicia and/or indicia of recreational drug usage without risk of compromising the individual's identity.
Still a further object of the immediate invention is the provision of a method, apparatus and system for collecting, storing and retrieving human health and/or medical data in a secure and tamper-free fashion that also guarantees that (i) the individual retrieving the data is also the individual to whom the human health and/or medical data are pertinent and (ii) that the individual retrieving the data has access only to medical records relevant to that specific individual and no other medical data.
Yet a further object of the invention is to provide a new system and method for anonymously testing for human HIV status and/or antigens or antibodies for human diseases and/or drug levels of therapeutic drugs known to be used in treatment of infectious diseases and/or drug levels of "recreational" drugs.
And still a further object of the invention is the provision of method and apparatus, according to the foregoing, which is intended to allow rapid, real-time access to human health and/or medical data and the date of collection of the sample from which the data are derived, by only the donor of the sample from which the information is derived, while preserving the anonymity of the test subject and also providing any other party with whom the test subject chooses to share the data great confidence that the data apply to the test subject.